PEA and Scutellaria combined with exercise for chemotherapy-related nerve pain
Official title: Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial
Run by University of Palermo · NCT07352514 · Data updated 2026-11-12
This trial will see if taking PEA and Scutellaria together with therapeutic exercise helps adults who have nerve pain after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Palermo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Palermo, Italia) |
| Status | Recruiting |
| Started | March 15, 2025 |
| Main results expected | February 20, 2026 |
| Study ends | April 2026 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT07352514 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older who developed neuropathic pain (NRS ≥ 5) after chemotherapy within the prior six months and who can follow the EXCAP exercise program may be eligible.
✕Probably not a fit
People with diabetic neuropathy, severe liver impairment, hypersensitivity to PEA, or severe disabilities preventing exercise are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort in which adults with chemotherapy-induced peripheral neuropathy will be enrolled and followed while receiving post-market nutraceuticals and supervised exercise. Participants will be grouped to compare those receiving PEA plus Scutellaria with standardized therapeutic exercise against other treatment approaches. Outcomes will include patient-reported neuropathic pain severity and measures of nerve health over the follow-up period. The study uses a standardized exercise protocol (EXCAP) and requires a minimum opioid washout to limit confounding from opioid pain control.
Why it matters
Potential benefit: If successful, the combined nutraceutical and exercise approach could reduce neuropathic pain and improve nerve function and quality of life for people with CIPN.
How similar studies have gone: Smaller studies and case reports have suggested PEA can help neuropathic pain, but combining PEA and Scutellaria with structured exercise is relatively novel and not well established in randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older. * Patients who have undergone chemotherapy treatment within the previous 6 months. * Patients treated with PEA, Scutellaria, and standardized therapeutic exercise according to the EXCAP protocol from April 2025 to September 2025. * Patients with a washout period from opioid-based analgesic therapy of at least 10 days or who are not receiving opioid-based analgesic therapy. * Patients presenting with neuropathic pain (NRS ≥ 5). * Patients able to provide written informed consent. Exclusion Criteria: * Patients younger than 18 years. * Patients with hypersensitivity to PEA or any of the excipients listed in the Summary of Product Characteristics (SPC). * Patients with diabetic pathology. * Patients with severe hepatic impairment. * Patients with severe disabilities that compromise the execution of therapeutic exercise.
Where it's running
-
A.O.U.P. P. Giaccone, Palermo, Italia 90127
Palermo, Italia, Italy Recruiting
Study contacts
- Study coordinator: Giulia Letizia Mauro
- Email: giulia.letiziamauro@unipa.it
- Phone: +39 0916554160 +39 09165541
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.